Clinical trial · Interventional
Development of Fluorescent Lectin Tracers With Dedicated Technology for in Vivo Detection of Esophageal Dysplasia in Barrett Patients
Glycan Near-Infrared Imaging Using Fluorescently Labeled Wheat Germ Agglutinin (WGA): Evaluation of Safety and Feasibility in a Prospective Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to evaluate the feasibility of WGA-800CW with dedicated imaging systems for detection of invisible esophageal dysplasia in patients with Barrett's esophagus. The main questions it aims to answer are: * What is the optimal dose of WGA-800CW that maximizes the tumor-to-background ratio and enables clear visualization of the tumor? * Can fluorescence endoscopy with WGA-800CW in combination with qFME detect dysplastic esophageal lesions? In this non-randomized, non-blinded, prospective, feasibility intervention study, 49 participants with Barrett's esophagus will be included. Patients will undergo the combined procedure (qFME and/or OCT-NIRF and HD-WLE). WGA-800CW will be topically administered via a spray catheter during gastroscopy procedures and fluorescent signal will be assessed with qFME and/or OCT-NIRF.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus Adenocarcinoma | — | UNRESOLVED | — |
| Barrett's Esophagus With or Without Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WGA-800CW | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- WGA-800CW
- interventionNames
- Drug: WGA-800CW
Primary outcomes (5)
- measure
- Determine the optimal dose of WGA-800CW (study part A)
- timeFrame
- From enrollment to inclusion and data assessment of patient 9.
- description
- Visual evaluation and distinction of tracer during FME (visible signal yes/no)
- measure
- Determine the optimal dose of WGA-800CW (study part A)
- timeFrame
- From enrollment to inclusion and data assessment of patient 9.
- description
- Calculating Target-to-background ratio's by dividing fluorescence intensity of target (dysplastic lesion) by the fluorescence intensity of the background (non-dysplastic BE).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with confirmed Barrett's esophagus, esophageal dysplasia, or superficial esophageal ade-nocarcinoma. * Patients scheduled for gastroscopy procedure within the UMCG. * Able to provide written informed consent. Exclusion Criteria: * Known allergy to wheat. * Celiac disease. * Dermatitis herpetiformis. * Pregnancy or breastfeeding.
References
Publications (0)
Data not yet available